Near-Infrared Fluorescence Imaging with Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery (INOCA)

Istanbul University

Status and phase: Not yet enrolling; Phase 4

Conditions: Vulvar Cancer; Gynecologic Cancers; Cervical Cancers; Ovarian Cancer; Endometrial Cancers; Anastomotic Leaks

Treatments: Device: Near-Infrared Fluorescence Imaging System; Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT06871787

07.01.2025-3097444

Details and patient eligibility

About

The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations.

The main question it aims to answer is: Does using ICG fluorescence imaging during bowel anastomosis reduce the rate of complications such as leaks, infections, and abscesses within 30 days after surgery? Participants are women aged 18 and older undergoing surgery for gynecologic cancers (such as ovarian, uterine, cervical, or vulvar cancer). During surgery, investigators will inject ICG intravenously, then use a special near-infrared camera to see how well blood flows at the anastomosis site. The investigators will then decide if the reconnection is good enough or needs adjustment.

Researchers will record any complications within the first 30 days after surgery to understand if this imaging method helps reduce surgical risks.

Full description

In gynecologic cancer surgeries, complete removal of the tumor often requires bowel resection (removal of part of the intestine). After resection, surgeons perform bowel anastomosis to restore gastrointestinal continuity. However, anastomosis can sometimes fail, leading to complications such as leaks, pelvic abscesses, or infections. Such complications significantly affect patient health, recovery, and outcomes.

Indocyanine green (ICG) is a dye approved by health authorities for clinical use. When injected into the bloodstream, it glows brightly under near-infrared (NIR) light, allowing investigators to visually assess blood flow in tissues during surgery. Good blood flow is critical for proper healing of the bowel reconnection.

This study aims to evaluate the effectiveness of using ICG-enhanced NIR fluorescence imaging specifically during gynecologic oncology surgeries involving bowel resections. After surgeons complete the anastomosis, ICG will be administered intravenously. Investigators will then examine the blood flow at the anastomosis site using a special near-infrared camera. If the blood flow appears insufficient, investigators may choose to revise the bowel connection during the same operation.

The study will include approximately 50 women undergoing surgery for gynecologic cancers such as ovarian, uterine, cervical, or vulvar cancer. The primary goal is to determine whether the use of this imaging technique reduces complications, especially within the first 30 days after surgery.

The results of this research could lead to safer surgical procedures, improved patient outcomes, and potentially influence clinical practice guidelines in gynecologic oncology.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients aged 18 years or older.
• Diagnosis of gynecologic cancer (ovarian, endometrial, cervical, vulvar) requiring surgical treatment.
• Planned bowel resection and anastomosis during gynecologic oncology surgery.
• Ability and willingness to provide informed consent.

Exclusion criteria

• Known allergy or hypersensitivity to indocyanine green (ICG).
• Pregnancy or breastfeeding at the time of surgery.
• Severe liver or kidney dysfunction limiting the use of ICG.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

ICG Fluorescence Imaging Group

Experimental group

Description:

Women undergoing gynecologic oncology surgery with bowel resection and anastomosis. Anastomotic perfusion will be evaluated intraoperatively using indocyanine green (ICG) enhanced near-infrared fluorescence imaging.

Treatment:

Drug: Indocyanine Green

Device: Near-Infrared Fluorescence Imaging System